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RSS FeedPosted by Michael Wonder on 14 Jul 2020
Aspen offers to cut cancer drug prices, may avoid EU antitrust fine
14 July 2020 - Aspen has offered to cut prices by an average of 73% for six off-patent cancer drugs, ...
Posted by Michael Wonder on 14 Jul 2020
Verrica Pharmaceuticals receives complete response letter from the FDA for its new drug application for VP-102 for the treatment of molluscum contagiosum
14 July 2020 - Complete response letter requests additional chemistry, manufacturing, and controls and human factors information. ...
Posted by Michael Wonder on 14 Jul 2020
Teva announces availability of ProAir Digihaler (salbutamol sulphate 117 mcg) inhalation powder for patients with asthma and COPD
13 July 2020 - First and only digital rescue inhaler with built-in sensors now available by prescription to patients in the ...
Posted by Michael Wonder on 13 Jul 2020
FDA advises CytoDyn its application is incomplete
13 July 2020 - CytoDyn announced today it has received a refusal to file letter from the U.S. FDA regarding ...
Posted by Michael Wonder on 13 Jul 2020
TGA publishes more details on its approval of COVID-19 medicine Veklury
13 July 2020 - Remdesivir granted conditional approval in record time. ...
Posted by Michael Wonder on 13 Jul 2020
Pfizer and BioNTech granted FDA fast track designation for two investigational mRNA-based vaccine candidates against SARS-CoV-2
13 July 2020 - Anticipated large, global Phase 2b/3 safety and efficacy study may begin as early as July 2020. ...
Posted by Michael Wonder on 13 Jul 2020
Ipsen announces updated indication for Dysport (abobotulinumtoxinA) for the treatment of spasticity in children
10 July 2020 - Dysport is now FDA approved to treat both upper and lower limb spasticity in paediatric patients two ...
Posted by Michael Wonder on 12 Jul 2020
COVID-19 is forcing us to rethink clinical trials for cancer treatments
9 July 2020 - Participation rates were already low, but the pandemic threatens to drive them even lower. ...
Posted by Michael Wonder on 12 Jul 2020
Australian vaccine trial starts today
13 July 2020 - Australian scientists are on track to deliver a COVID-19 vaccine this year, with the start on Monday ...
Posted by Michael Wonder on 12 Jul 2020
Remdesivir: US purchase of world stocks sparks new “hunger games,” warn observers
3 July 2020 - The US has bought up almost all the world’s supply of the antiviral drug remdesivir in ...
Posted by Michael Wonder on 11 Jul 2020
Australia's first COVID treatment approved
10 July 2020 - The Therapeutic Goods Administration has granted provisional approval to remdesivir (Veklury, Gilead Sciences) as the first ...
Posted by Michael Wonder on 10 Jul 2020
FDA approves expanded Botox (onabotulinumtoxinA) label for the treatment of paediatric patients with spasticity
9 July 2020 - Updated label now includes paediatric patients with lower limb spasticity caused by cerebral palsy. ...
Posted by Michael Wonder on 10 Jul 2020
Leo Pharma announces U.S. FDA acceptance of biologics license application for tralokinumab for the treatment of adults with moderate-to-severe atopic dermatitis
9 July 2020 - Submission includes data from pivotal ECZTRA 1, 2 and ECZTRA 3 Phase 3 studies evaluating safety and ...
Posted by Michael Wonder on 09 Jul 2020
ChemoCentryx submits new drug application to the U.S. FDA for avacopan in ANCA associated vasculitis
9 July 2020 - ChemoCentryx today confirmed that the Company has submitted a new drug application to the U.S. FDA ...
Posted by Michael Wonder on 09 Jul 2020
Osmotica Pharmaceuticals receives FDA approval for Upneeq (oxymetazoline hydrochloride ophthalmic solution), 0.1% for acquired blepharoptosis (droopy eyelid) in adults
9 July 2020 - First and only FDA approved pharmacologic treatment for acquired blepharoptosis. ...